- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04132791
TIME ASPIRIN: Chronotherapy With Aspirin for Reduction of Cardiovascular Disease (TImE ASPIRIN)
Chronotherapy With Aspirin for Reduction of Cardiovascular Disease
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zuid-Holland
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Leiden, Zuid-Holland, Netherlands, 2333 ZA
- Leiden University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Use of low-dose aspirin (acetylsalicylic acid 80mg [brand name: acetylsalicylic acid cardio TEVA]~)
- Patients using aspirin from an MDD ('Baxter')
- Capacity to give informed consent (IC)
Exclusion Criteria:
- Pregnancy
- Mental or physical disability to fulfil study requirements
- Insufficient knowledge of the Dutch language
- Patients currently participating in another (clinical) trial or study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: aspirin after awakening + placebo before bedtime
Acetylsalicylic acid 80 mg once daily, orally. Intake in de morning after awakening. Participants already use acetylsalicylic acid 80 mg once daily due to secondary prevention of cardiovascular disease. Placebo tablet once daily will be added to their medication. The placebo tablet will be taken before bedtime, orally. The placebo is given throughout the study. |
determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after wakening and aspirin before bedtime.
Other Names:
|
Experimental: placebo after awakening +aspirin before bedtime
Acetylsalicylic acid 80 mg once daily, orally. The time will be changed form morning to bedtime. Participants already use acetylsalicylic acid 80 mg once daily due to secondary prevention of cardiovascular disease. Placebo tablet once daily will be added to their medication. The placebo tablet will be taken after awakening, orally. The placebo is given throughout the study. |
determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after wakening and aspirin before bedtime.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rate of major adverse cardiovascular events
Time Frame: maximum of 4 years follow up
|
the difference in number of participants with a major adverse cardiovascular events, defined as the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, transient ischemic attack, need for repeat revascularízation by redo-CABG or repeat percutaneous intervention.
|
maximum of 4 years follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparing the incidence rate of major cardiovascular events between the two groups in the morning (6-12), evening (12-21) and night (21-6).
Time Frame: maximum of 4 years follow up
|
It is expected that bedtime aspirin reduces the number of participants with primary outcome (major cardiovascular events) more during morning hours (6-12h) compared with the rest of the day.
So we will compare the mornig events, afternoon/evening and night events between the two groups and compare the difference.
|
maximum of 4 years follow up
|
Incidence rate of side-effects between the 2 groups
Time Frame: maximum of 4 years follow up
|
the difference between the 2 groups of the number of participants that experience side-effects (e.g.
bleeding, gastrointestinal symptoms)
|
maximum of 4 years follow up
|
cost-effectiveness of the intervention
Time Frame: maximum of 4 years follow up
|
Comparing the relative costs and outcomes (effects) between the 2 groups.
Data from questionnaire (use of health care) and data from the primary and secondary health care systems.
We can compare the use of health care between the two groups en we can calculate the difference in cost between the two groups.
So we can estimate if our intervention is cost-effective.
|
maximum of 4 years follow up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
difference in quality of life
Time Frame: maximum of 4 years follow up
|
Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Rated level per dimensions can be coded as a number 1-5, which indicates having no problems for 1 and having extreme problems for 5.
We can define 3,125 (=55) different health states.
We compare the average health status of the groups at the beginning and at the end of the study.
See if there is a difference in health status/ quaulity of life between the two groups.
|
maximum of 4 years follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tobias Bonten, Leiden University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- P18.127
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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